Regulatory

Every AR/VR device the FDA has authorized.

120 devices from 70 companies, copied from the FDA's own list and checked for changes every day. Each row links to its FDA database record.

This is the regulator's list, shown as published. FDA authorization means a device may be marketed in the US for its stated use; it is not evidence of clinical effectiveness and not an AVRMD endorsement. Source: FDA, Augmented Reality and Virtual Reality Medical Devices (FDA page updated 2026-09-04).

9 devices
  1. 2023-12-05Ceevra Reveal 3+Ceevra, Inc.RadiologyK233568
  2. 2023-10-16IkshanaImmersiveTouchRadiologyK230249
  3. 2023-09-14OrionXRHoth Intelligence Inc.RadiologyK232189
  4. 2023-07-14CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)SentiAR, Inc.AVRMD record: SentiARRadiologyK223290
  5. 2023-07-13XR90 (XR90-SYS)MediView XR, Inc.RadiologyK223125
  6. 2023-05-24Avatar Medical Software V1Avatar MedicalRadiologyK222035
  7. 2023-05-01CarnaLife HoloMedApp S.A.RadiologyK221870
  8. 2023-04-25Ceevra Reveal 3Ceevra, Inc.RadiologyK222676
  9. 2023-02-24Clarus ViewerClarus Viewer CorporationRadiologyK222757